2,328 results · 24ms · Sources: EU EUDAMED, US FDA

Implant, Auditory Brainstem

FDA Pre-Market Approval
FDA Class 3 ·Auditory Brainstem Implant

Sensor, Glucose, Invasive

FDA Pre-Market Approval
FDA Class 3 ·Medtronic MiniMed iPro2 CGM System with Enlite Sensor

Sensor, Glucose, Invasive

FDA Pre-Market Approval
FDA Class 3 ·DEXCOM G4 PLATINUM CONTINUOUS MONITORING SYSTEM, DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

Stent, Urethral, Prostatic, Permanent Or Semi-Permanent

FDA Pre-Market Approval
FDA Class 3 ·UROLUME(TM)ENDOPROSTHESIS

Automated Insulin Dosing , Threshold Suspend

FDA Pre-Market Approval
FDA Class 3 ·Medtronic MiniMed 630G System

Ventricular (Assist) Bypass

FDA Pre-Market Approval
FDA Class 3 ·HeartWare™ HVAD System

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·TECNIS® Foldable Acrylic IOL with OptiEdge, Model ZA9003

Sensor, Glucose, Invasive

FDA Pre-Market Approval
FDA Class 3 ·Medtronic MiniMed Paradigm Real-Time Revel System

Implanted Brain Stimulator For Epilepsy

FDA Pre-Market Approval
FDA Class 3 ·NeuroPace® RNS® System

Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing

FDA Pre-Market Approval
FDA Class 3 ·NexGen® LPS-Flex / LPS-Mobile Bearing Knee

Lens, Multifocal Intraocular

FDA Pre-Market Approval
FDA Class 3 ·TECNIS® Multifocal 3-Piece IOL, Model ZMA00

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·SENSAR® Soft Acrylic Posterior Chamber IOL

Automated Insulin Dosing , Threshold Suspend

FDA Pre-Market Approval
FDA Class 3 ·Medtronic MiniMed 530G System

Implant, Anti-Gastroesophageal Reflux

FDA Pre-Market Approval
FDA Class 3 ·LINX REFLUX MANAGEMENT SYSTEM

System, Appendage Closure, Left Atrial

FDA Pre-Market Approval
FDA Class 3 ·WATCHMAN FLX Left Atrial Appendage Closure Device with Delivery System; WATCHMAN FLX Pro Left Atrial Appendage Closure D

Automated Insulin Dosing Device System, Single Hormonal Control

FDA Pre-Market Approval
FDA Class 3 ·Medtronic MiniMed 670G System

Automated Insulin Dosing , Threshold Suspend

FDA Pre-Market Approval
FDA Class 3 ·ENLITE GLUCOSE SENSOR

Automated Insulin Dosing , Threshold Suspend

FDA Pre-Market Approval
FDA Class 3 ·ENLITE SENSOR

Sensor, Glucose, Invasive

FDA Pre-Market Approval
FDA Class 3 ·SOF-SENSOR

Stimulator, Autonomic Nerve, Implanted For Epilepsy

FDA Pre-Market Approval
FDA Class 3 ·NEUROCYBERNETIC PROSTHESIS (NCP) SYSTEM